Effect of duration of injection on width of bruising and intensity of pain associated with subcutaneous low molecular weight heparin in hospitalized patients: A clinical trial study
This study is a randomized clinical trial aimed at determining the effect of duration of injection on the area of bruising and pain of injection following enoxaparin subcutaneous injection. A total of 98 patients admitted in the Shohadaye-Khalije Fars Hospital in Bushehr will be enrolled. For each patient, two subcutaneous injections of 10-second duration (Technique A) on the right side of the abdomen (right of umbilicus) and 30-second duration injection (technique B) in the left abdomen (left of umbilicus) will be done symmetrically. Enoxaparin (6000 IU or 4000 IU) will be injected by a trained nurse randomly to either right or left side of abdomen with a 12 or 24 hour interval (according to the prescribed medication) outside a 50 mm radius of the umbilicus. After every injection, a circle of radius 5 cm is drawn around the injected area by using a waterproof marker, avoiding for re-selection, and that area is marked for bruises evaluation. The area of bruising, 48 hrs and 72 hrs after the injection and pain of injection, immediately, will be measured for all the patients and compared for two sides of abdomen.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112208473N1
Registration date:2013-09-12, 1392/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-12, 1392/06/21
Registrant information
Name
Masoud Bahreini
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 3836
Email address
m.bahreini@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of duration of injection on width of bruising and intensity of pain associated with subcutaneous low molecular weight heparin in hospitalized patients: A clinical trial study
Public title
Effect of duration of injection on width of bruising and intensity of pain associated with subcutaneous low molecular weight heparin in hospitalized patients: A clinical trial study
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age greater than 18 years; newly admitted patients; orientation to person/place/time/situation; able to rate the pain perceived at the injection site;
Exclusion criteria: coagulation disorders (thrombocytopenia and PT, PTT, INR, LFT impaired); Presence of scar tissue, any skin lesion or unilateral senso neural obvious defects or damage and abdominal trauma at the injection areas; receiving other anticoagulants such as warfarin and heparin
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Campous of Bushehr Univeristy of Medical Sciences, Salman Farsi St., Bushehr, Iran
City
Bushehr
Postal code
7518759577
Approval date
2013-06-18, 1392/03/28
Ethics committee reference number
B-15-92-4
Health conditions studied
1
Description of health condition studied
Thromoembolism
ICD-10 code
T80.1
ICD-10 code description
Vascular complications following infusion, transfusion and therapeutic injection
Primary outcomes
1
Description
Bruising
Timepoint
48 hours and 72 hours after injection
Method of measurement
Area of bruising in squared milimeter by an special software
Secondary outcomes
1
Description
Pain intensity
Timepoint
Immediately after injection
Method of measurement
A numerical scale from 0 to 10
Intervention groups
1
Description
Subcutaneous injection of Enoxaparine (6000 IU or 4000 IU) over 30 seconds
Category
Treatment - Drugs
2
Description
Subcutaneous injection of Enoxaparine (6000 IU or 4000 IU) over 10 seconds
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye-Khalije Fars Hospital
Full name of responsible person
Azar Dadain
Street address
Shohadaye-Khalije Fars Hospital
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostovar
Street address
Campous of Bushehr Univeristy of Medical Sciences, Salman Farsi St., Bushehr, Iran
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Azar Dadain
Position
MS in Nursing
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Pardis Site, Salman-e Farsi st, Bushehr, Iran.
City
Bushehr
Postal code
Phone
+98 77 1345 3500
Fax
Email
azar.dadain@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Masould Bahreini
Position
PhD in Nursing
Other areas of specialty/work
Street address
Campous of Bushehr Univeristy of Medical Sciences, Salman Farsi St., Bushehr, Iran
City
Bushehr
Postal code
7518759577
Phone
+98 77 1455 3836
Fax
Email
msdbahreini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Azar Dadain
Position
MS Student of nursing
Other areas of specialty/work
Street address
Campous of Bushehr Univeristy of Medical Sciences, Salman Farsi St., Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 1253 4960
Fax
Email
azar.dadain@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)